Primary Device ID | 00802526559006 |
NIH Device Record Key | 2c51ad95-107a-415c-bf1a-58b0b8003efb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ESSENTIO™ MRI EL DR |
Version Model Number | L131 |
Company DUNS | 106295384 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00802526559006 [Primary] |
LWP | Implantable pulse generator, pacemaker (non-CRT) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-11-04 |
Device Publish Date | 2016-05-10 |
00191506034429 - RHYTHMIA HDx™ | 2024-03-11 Ablation Connection Box |
00191506020408 - IntellaNav StablePoint™ Cable | 2024-03-08 Catheter Cable |
08714729419396 - Percuflex™ | 2024-03-08 Ureteral Stent |
08714729992233 - INTELLANAV STABLEPOINT™ | 2024-03-08 Ablation Catheter |
08714729992240 - INTELLANAV STABLEPOINT™ | 2024-03-08 Ablation Catheter |
00191506019570 - Rubicon™ Control | 2024-02-26 Support Catheter |
00191506019594 - Rubicon™ Control | 2024-02-26 Support Catheter |
00191506019617 - Rubicon™ Control | 2024-02-26 Support Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ESSENTIO 85873570 4813272 Live/Registered |
Cardiac Pacemakers, Inc. 2013-03-12 |
ESSENTIO 79244262 not registered Live/Pending |
FABER-CASTELL AKTIENGESELLSCHAFT 2018-09-07 |
ESSENTIO 77616866 3727384 Dead/Cancelled |
ASUSTEK COMPUTER INCORPORATION 2008-11-18 |